Regulatory System Associate
4 weeks ago
The purpose of this role is to manage the regulatory information management (RIM) system for all Consumer Healthcare products worldwide to support key regulatory processes and enable the company to meet its regulatory, legal and pharmacovigilance obligations. This role is responsible for the operation of the regulatory systems and processes used to prepare and store regulatory submissions, labelling, planning/tracking and generating KPIs/metrics and compliance reports. This role will work closely with central, regional and key local regulatory CH teams, and key external regulatory agencies/trade associations to ensure key information is provided to meet internal/external compliance databases (e.g. EU Art 57) and PV systems. This role will proactively evaluate systems and processes and recommend improvement activities to enhance the speed of innovation delivery and deliver efficient compliance via targeted KPIs.
Key Responsibilities
Identify and drive system or process changes to enhance data quality, user experience and compliance.
Provide guidance and support for related initiatives, including system upgrades and enhancements in support of regulatory processes and obligations.
Monitor system performance and ensure that performance or capability issues are resolved effectively.
Partner with IT colleagues on system implementation and change control activities, including development of iQMS IT quality documentation to support user acceptance, including test scripts and reports.
System reports:
Support in managing the design, validation and delivery of regulatory reports for compliance and dept. KPIs.
Ensure timely delivery of ad-hoc and regular reports.
Data compliance:
Ensure capture of high data quality regulatory data.
Identify and communicate data errors and inconsistencies, and drive data remediation initiatives as required.
Manage the delivery of compliance reports required to support business stakeholders.
User training and support:
Delivery of effective system user training and system access promoting compliant use of RIMs application.
Ensure up to date process documentation, training materials and user guides.
Provide Systems Administration, including management of user access and roles.
Provide day-to-day support to the users.
Champion the importance of registration tracking within the organisation through regular communication with global stakeholders.
Other Activities
Support as necessary other activities related to Systems team
Previous Experience Required:
Bachelor’s degree (or equivalent experience)
2 years’ experience in regulatory operations (or similar) role
Experience within pharmaceutical organisation, in particular Regulatory Affairs.
Understanding of global regulatory affairs processes
Familiarity with the range and types of non-prescription healthcare products, including over-the-counter (OTC) medicines, cosmetics and devices.
Awareness/experience of EMA EudraVigilance, Medicinal Product Dictionary (EVMPD) requirements. Advanced knowledge of Regulatory Information Management.
Familiarity with database applications, concepts and reporting.
Experience of project and business analysis.
Excellent understanding of standard IT applications, including advanced use of Microsoft Excel to manipulate reports and summarise data.
Knowledge of Insight Manager application.
Knowledge of cloud based applications.
Familiarity with systems validation and project quality methodologies (e.g. iQMS, Agile)
Clear and accurate editorial skills to ensure data reported is consistent and meaningful.
Excellent organisational and coordination skills
Care to join us. Find out what life at Haleon is really like At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.
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